MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG CERAMIC CERAMIC BALL HEAD FORTE 28L; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number 75004171

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 12/02/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after a thr surgery performed on (b)(6) 2006, the ceramic head 28l <=> 16153 implanted broke.A revision surgery is planned for (b)(6) 2022, in order to explant the broken implant.Current health status of the patient is unknown.

Manufacturer Narrative

H3, h6: it was reported that, after a total hip replacement surgery performed on (b)(6)2006, the implanted ceramic ball head forte 28l.Current health status of the patient is unknown.The implanted device was not returned for investigation.A product evaluation was not possible.No batch number was communicated so the document history review was not possible.Based on the available information it is not possible to investigate whether the reported device met manufacturing specifications upon release for distribution.Due to insufficient information it is not possible to perform a review of past corrective actions.A complaint history review was performed, and it was found that the occurrence and severity of the reported failure mode is anticipated with a low risk level as per risk management.A review of the risk management documentation verifies the failure mode, occurrence and severity of the reported issue.Insufficient information was made available to determine the revision of the instructions for use applicable to the device at the time of manufacturing.However, a review of the current revision was conducted and it revealed that the instructions for use states "implant component fracture" of the component as a ¿potential medical device problems¿ in combination with the implantation of a hip prosthesis.No clinically sufficient data was provided to perform a thorough medical investigation, thus the clinical root cause of the broken ceramic head cannot be confirmed.The performed investigation do not lead to an accurately determined cause.Due to insufficient information, it is not possible to speculate about factors which could have contributed to the reported event.There is no need for further actions because of the limited information provided.Nevertheless, smith + nephew will continue to monitor this device for similar issues.This complaint will be reopened should additional information or the device be received.

• Brand Name: CERAMIC CERAMIC BALL HEAD FORTE 28L
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16048744
• MDR Text Key: 306156871
• Report Number: 9613369-2022-00607
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 75004171
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male